AbbVie has applied for approval from the U.S. Food and Drug Administration (FDA) for a new formulation of its hepatitis C virus (HCV) treatment Viekira Pak (ombitasvir/paritaprevir/ritonavir; dasabuvir) that requires once-daily dosing instead of the current twice-daily dosing. The application seeks an indication for people with genotype 1 of the virus.
The pharmaceutical company has proposed a once-daily dose of three tablets—each of which include ombitasvir, paritaprevir, dasabuvir and ritonavir—to be taken with a meal and to be used with or without twice-daily ribavirin. Currently, people treated with Viekira Pak take three tablets in the morning and one in the evening, both with a meal.
The FDA application includes two studies of how the new formulation affects drug levels in the body.
To read the a press release about the application, click here.
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